Biofrontera AG: BIOFRONTERA REPORTS RESULTS FOR THE FIRST HALF OF 2024

Leverkusen, Germany (pta028/30.09.2024/15:05) - Biofrontera AG (ISIN: DE000A4BGGM7), an international biopharmaceutical company, today announced its financial results for the first six months ended June 30, 2024.

"Our positive progress in Europe clearly demonstrates the success of our strategic focus on this market. The 18% increase in revenue in Germany and the 61% solid growth from our European licensees underline the continuous expansion in this key market. The licensing deal recently signed with LEO Pharma and new distribution partnerships for artificial daylight further strengthen our market position. Additionally, the transfer of clinical research to Biofrontera Inc. in June will lead to significant cost reductions and improved predictability of future expenditures. These developments are pivotal steps towards reducing our dependency on the U.S. business and paving the way for sustained growth in Europe.," commented Pilar de la Huerta, CFO of Biofrontera AG, on the half-year results released today.

Biofrontera reported total revenue of 7,206 TEUR for the period from January 1 to June 30, 2024, compared to 17,784 TEUR in the first half of 2023, representing a 59% decline. The revenue decrease is due to significantly reduced income from the U.S. licensing business. Biofrontera Inc., the U.S. licensee, changed its inventory policy at the end of the last fiscal year and did not order any Ameluz® during the reporting period. As a result, U.S. revenue decreased by 92%. The positive revenue development in Europe could not fully offset this decline. Biofrontera AG will deliver new Ameluz® orders to Biofrontera Inc. in Q4 2024.

In Germany, revenue increased by 532 TEUR to 3,554 TEUR during the reporting period, representing an 18% increase. This positive development underscores the strong market position of Ameluz® in Biofrontera AG's home market. The product has successfully adapted to patient needs and market conditions through continuous adjustments. Ameluz® remains the market leader in the photodynamic therapy (PDT) segment, and the expansion of approval for use with artificial daylight is expected to provide additional momentum in this fiscal year.

In Spain, the revenue level has not yet returned to its previous growth momentum after the repeal of the regulatory price decree in 2022. Revenue generated in Spain recorded a slight decline to 923 TEUR (956 TEUR; -3%).

The direct sales business in the United Kingdom achieved 30% growth on a lower revenue base, reaching 465 TEUR, reflecting the initial positive effects of significantly increased coverage of NHS hospitals since last year.

With European licensees, Biofrontera generated revenue of 1,148 TEUR in the first six months of 2024, compared to 715 TEUR in the same period of 2023, representing a significant increase of 61%. The in-market sales of license partners in Austria, the Nordic countries, and Switzerland continue to show very solid growth.

On the cost side, research and development expenses decreased by 3% to 3,821 TEUR during the reporting period compared to 3,936 TEUR in the prior-year period. The company expects a relevant reduction after June when the clinical program was transferred to Biofrontera Inc. General administrative expenses amounted to 1,900 TEUR in the first half of 2024, representing a total decrease of 1,533 TEUR compared to the prior-year period (3,433 TEUR). This decline is due to the absence of additional legal and consulting expenses related to the company's restructuring. Sales and marketing expenses amounted to 3,306 TEUR in the first half of 2024, compared to 3,661 TEUR in the prior-year period.

The Group's EBITDA decreased by 7,300 TEUR to -3,557 TEUR in the first half of 2024, compared to 3,743 TEUR in the prior-year period. EBIT also showed a significantly more negative result at -3,965 TEUR (prior-year period: 3,357 TEUR). These results are attributable to the significantly reduced USA revenue level, which has deteriorated due to the changed inventory policy of our U.S. licensee.

Cash and cash equivalents amounted to 2,214 TEUR as of June 30, 2024 (December 31, 2023: 3,080 TEUR), following the successful capital increase with net proceeds of approximately 3.3 million EUR.

Outlook

At the end of June, Biofrontera AG and Biofrontera Inc were sued by a competitor in the United States, alleging that Biofrontera infringed certain lamp patents of this competitor. The competitor has filed two separate cases, one for two patent infringements infront of the District Court and a second infront of the ITC (International Trade Commission) with the goal of banning the import of the Biofrontera XL lamp into the United States. Biofrontera AG and its subsidiaries have entered into a joint defense agreement with Biofrontera Inc. to share legal costs. The costs of the ITC proceedings are expected to amount to 5 million USD over a period of 18 months, which will be shared between the two companies. The forecast for the 2024 fiscal year has been adjusted based on this new information.

The revised forecasted key performance indicators are as follows:

Based on the current 2024 business plan, the Group will have sufficient liquidity to meet all obligations for an additional 12 months from the date of preparation. Assuming expenses and revenues develop as planned and considering the previously mentioned capital measure, the Group expects to have cash and cash equivalents of between 1 and 3 million EUR as of December 31, 2024.

Details of the business figures as of 30 June 2024 can be found in the half-year financial report, which is published on the Biofrontera AG website at https://www.biofrontera.com/en/investors/financial-reports ( https://www.biofrontera.com/en/investors/financial-reports. )

Key Financial Figures and Business Performance for the First Half of 2024 (unaudited)

- end -

About Biofrontera AG

Biofrontera AG is an international specialty pharmaceutical company focused on the development and commercialization of innovative dermatological products. With a strong focus on the European market, the company strives for sustainable growth and long-term profitability.

This press release contains forward-looking statements based on current assumptions and forecasts by the management of Biofrontera AG. Known and unknown risks, uncertainties, and other factors could lead to material differences between the actual results, financial situation, or development of the company and the estimates provided here.

(Ende)